Atossa to Present a Trial in Progress Poster on its Neoadjuvant Breast Cancer Phase 2 Clinical Trial, EVANGELINE, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
09 May 2023 - 11:15PM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative proprietary
medicines to address significant unmet needs in oncology with a
current focus on breast cancer, today announces that a Trial in
Progress poster for the Phase 2 clinical study of (Z)-endoxifen in
premenopausal women with early stage ER+ / HER2- breast cancer will
be presented at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago.
"We're excited to present an overview of our
ongoing Phase 2 study, EVANGELINE, at the 2023 ASCO annual
meeting," said Dr. Steven Quay, Atossa’s President and Chief
Executive Officer. "The EVANGELINE study is one of two ongoing
Phase 2 trials investigating our proprietary (Z)-endoxifen as a
neoadjuvant treatment for women with estrogen receptor positive
breast cancer. We look forward to sharing more about this novel
compound as we further our work to address unmet clinical needs
across the continuum of breast cancer prevention and
treatment."
Details of the presentation are:
- Abstract: TPS633 Poster Bd#
454a
- Abstract Title: A randomized phase 2
non-inferiority trial of (Z)-endoxifen and exemestane + goserelin
as neoadjuvant treatment for premenopausal women with ER+/HER2-
breast cancer (EVANGELINE)
- Session Title: Breast
Cancer—Local/Regional/Adjuvant
- Session Date and Time: Sunday, June 4, 2023,
8:00 AM-11:00 AM CT
- Presenter: Matthew P. Goetz, MD | Mayo
Clinic
The full abstract will become public at 5:00 pm ET
on Thursday, May 25, 2023.
About EVANGELINEEVANGELINE
(Endoxifen Versus exemestANe GosEreLIn, NCT05607004) is a
randomized non-inferiority study of (Z)-endoxifen compared to
exemestane plus goserelin as a neoadjuvant treatment for
premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer.
Participants receive neoadjuvant treatment for up to six months,
followed by surgery. The primary objective of the EVANGELINE study
is to determine whether the endocrine sensitive disease (ESD) rate,
measured by Ki-67 (a proliferation marker prognostic for disease
free survival), after four weeks of treatment with (Z)-endoxifen is
non-inferior to the ESD rate following treatment with current
standard of care, exemestane plus goserelin. Exemestane is an
aromatase inhibitor designed to block the synthesis of estrogen and
slow the growth of ER+ cancers. Goserelin is a medication given to
block the ovaries from making estrogen, which in premenopausal
women is associated with significant morbidity and inadequate
compliance, which compromises efficacy and increases the risk of
mortality.
About Premenopausal Patients with ER+ /
HER2- Breast CancerBreast cancer is the most frequently
diagnosed cancer in premenopausal women worldwide and accounts for
almost half of the cancers that occur in women aged 15-49. An
overwhelming majority (75%) of premenopausal breast cancer falls
under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian
function suppression, when combined with either tamoxifen or an
aromatase inhibitor, is the standard of care for the endocrine
management of stage 2 and 3 premenopausal ER+/HER2- breast
cancer.
About (Z)-Endoxifen(Z)-endoxifen
is the most active metabolite of the FDA approved Selective
Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others
have demonstrated that the therapeutic effects of tamoxifen are
driven in a concentration-dependent manner by (Z)-endoxifen. In
addition to its potent anti-estrogen effects, (Z)-endoxifen at
higher concentrations has been shown to target PKCβ1, a known
oncogenic protein.
Atossa is developing a proprietary oral formulation
of (Z)-endoxifen that does not require liver metabolism to achieve
therapeutic concentrations and is encapsulated to bypass the
stomach as acidic conditions in the stomach convert a greater
proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s
(Z)-endoxifen has been shown to be well tolerated in Phase 1
studies and in a small Phase 2 study of women with breast cancer.
We are currently studying (Z)-endoxifen in three Phase 2 studies:
one in healthy women with measurable breast density and two other
studies including the EVANGELINE study in women with ER+/HER2-
breast cancer. Atossa’s (Z)-endoxifen is protected by two issued
U.S. patents and numerous pending patent applications.
About Atossa TherapeuticsAtossa
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing innovative medicines in areas of significant unmet
medical need in oncology with a current focus on breast cancer. For
more information, please visit www.atossatherapeutics.com
CONTACTS:Kyle GuseGeneral Counsel
and Chief Financial Officerkyle.guse@atossainc.com
Eric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
FORWARD LOOKING
STATEMENTSForward-looking statements in this press
release, which Atossa undertakes no obligation to update, are
subject to risks and uncertainties that may cause actual results to
differ materially from the anticipated or estimated future results,
including the risks and uncertainties associated with any variation
between interim and final clinical results, actions and inactions
by the FDA, the outcome or timing of regulatory approvals needed by
Atossa including those needed to commence studies of (Z)-endoxifen,
lower than anticipated rate of patient enrollment, estimated market
size of drugs under development, the safety and efficacy of
Atossa’s products, performance of clinical research organizations
and investigators, obstacles resulting from proprietary rights held
by others such as patent rights, whether reduction in breast
density or in Ki-67 or any other result from a neoadjuvant study is
an approvable endpoint for (Z)-endoxifen, whether Atossa can
complete acquisitions, and other risks detailed from time to time
in Atossa’s filings with the Securities and Exchange Commission,
including without limitation its periodic reports on Form 10-K and
10-Q, each as amended and supplemented from time to time.
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